Canadian clinical trial registry

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Study Description

(from https://forpatients.roche.com/en/trials/cancer/solid-tumors/tumor-agnostic-precision-immuno-oncology-and-somatic-ta-50851.html)

This clinical trial is recruiting people who have advanced solid tumors that cannot be surgically removed. You (or your child) must have had genetic testing on the solid tumors that shows a positive result for one of the genetic changes, also known as biomarkers, being tested in this trial.

The purpose of this clinical trial is to compare the effects, good or bad, of different targeted therapies and immunotherapies in patients with solid tumors that cannot be surgically removed and show specific biomarkers.

To be able to take part in this clinical trial, you (or your child) must have been diagnosed with solid tumors that cannot be surgically removed and show one of the specific biomarkers that are being tested in this study:

• ROS1 fusion-positive tumors
• NTRK1/2/3 fusion-positive tumors
• TMB-high tumors
• ALK fusion-positive
• AKT1/2/3 mutant-positive tumors
• HER2 mutant-positive tumors
• PIK3CA multiple mutant-positive tumors
• BRAF class II mutant or fusion-positive tumors
• BRAF class III mutant-positive tumors
• RET fusion-positive tumors

Your doctor will be able to give you more information on the type of biomarker your solid tumors show. You must be otherwise in good health to take part. You will not be able to take part if you are pregnant or breastfeeding, or if you have received any recent treatment for your cancer. Some of the groups may have other specific requirements. Your doctor will be able to give you more information on this.

Inclusion Criteria

• Less than 18 years of age for cohort E and K
• Age between 12 and 17 years for cohorts E, F and H
• Diagnosis of advanced cancer that has spread to a different part of the body (metastasized) and can’t be removed by an operation (unresectable)
• Participants must be up and about at least 50% of their waking hours
• The cancer must have a specific genetic change in one of the following genes: ROS1, NTRK1/2/3, AKT, PIK3CA, HER2, BRAF, RET, or be TMB-high

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

 This study is eligible for STEP-1 funding. Find more information here. 

VICTORY is an early phase study for patients under 25 years who have a type of brain tumor called low grade glioma (LGG) that coms back or gets worse (recurrent or progressive). To participate on this study, the LGG must have certain genetic changes called CRAF or BRAF alterations.

The study has two parts:

Phase A: We are figuring out the best dose of a combination of two medicines, vinblastine and tovorafenib. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Phase B: After we find the right dose in Phase A, we'll test how well the combination of these drugs works. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Patients will be in the study for about two years unless their tumor gets worse (disease progression), they have bad side effects or they decide to withdrawal from the study.

Inclusion Criteria

• Patients must be less than or equal to 25 years of age at the time of enrollment
• Patient and/or their parent/guardian must sign an informed consent form to be enrolled on study
• Patients must have a diagnosis of low grade glioma (LGG) with a genetic alteration called BRAF or CRAF alteration that has come back (recurrent) or not responded to previous treatment (progressive)
• Patients must have completed at least 1 other therapy prior to enrollment on this study and recovered from its effects.
• Patients must have adequate performance status (daily activities which they are able to do) 
• Must have adequate organ function in bone marrow, kidneys, liver, heart and thyroid
• Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. 
• Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

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Study Description

Patients on this study will receive 4 doses of a vaccine called SurVaxM. While vaccines are usually thought of as ways to prevent diseases, vaccines can also be used to treat cancer. SurVaxM is designed to tell the body's immune system to look for tumor cells that express a protein called survivin and destroy them. If the body's immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence.

Inclusion Criteria

• Participant must have one of the following tumors that has progressed or come back: 
  • Medulloblastoma
  • Glioblastoma multiforme 
  • Anaplastic astrocytoma
  • High-grade astrocytoma, NOS
  • Anaplastic oligodendroglioma
  • Anaplastic ependymoma
  • Ependymoma 
  • Diffuse Intrinsic Pontine Gliomas (DIPG)
• Participant must be ≥ 1 year of age and ≤ 21 years of age at the time of screening.
• Participant or parent/guardian must be willing to sign a consent form and complete the study related assessments.
• Participants must have recovered from all previous cancer therapies. 
• Must be up and about for around 60% of the patient's waking hours
• Participants must meet all the blood work requirements 
• You cannot be pregnant or become pregnant on this study. If you are able to have children, you must use an acceptable form of birth control. Abstinence is included. 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

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Study Description

PBTC-049 tests a drug called savolitinib to see how well it works in children with these tumors. This drug has not been studied in children. The hope is that this drug may be a more effective treatment for these types of brain tumors in children.

Therefore, the primary goals of the study are to:

• Determine which dose of savolitinib is safe for children
• Learn what effects (good or bad) may occur when patients take savolitinib
• Learn how the body processes savolitinib

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Inclusion Criteria

• Patients with confirmed medulloblastoma, high-grade glioma, DIPG brain tumors, and other brain tumor types with a specific genetic marker, which continue to grow or have come back after the prior treatment may be eligible to participate.
• Patients must be between 5-21 years of age.
• Patients must have recovered from toxicities of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
• Pregnant women and nursing mothers are excluded from this study
• Patients or a parent/guardian must understand and sign a written consent form to participate
• Patients and/or their families must agree to the study visit requirements outlined in the consent form

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Other inclusion criteria may apply and will be discussed with you by the study team.

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Study Description

This study evaluates the safety of a type of treatment called HER2 CAR T cells (short for HER2 chimeric antigen receptor T cells). In addition to looking for side effects, we will study how well this treatment works against a brain tumor called ependymoma that has come back after treatment (recurrent) or has not responded well to treatment (progressive) in children. The HER2 CAR T cells used in this trial are made from the patient's own blood.

A new gene, called the HER2 CAR, will be inserted into patient's cells to allow them to recognize a protein on the tumor called HER2. These HER2-specific CAR T cells may be able to target and kill ependymoma tumors. This research is also studying how doable it is to provide this type of CAR T cell treatment to children being treated at different hospitals.

Inclusion Criteria

• Participants must have a diagnosis of ependymoma that is has come back or progressed.
• Patient must be ≥ 1 but ≤ 22 years of age at the time of enrollment for treatment.
• Participants must be up and about for 60% of their waking hours
• Patients must have received last dose of previous chemotherapy at least 21 days before enrollment.
• Patient must meet all organ function, bone marrow function and laboratory criteria
• The patient or parent/guardian can understand the consent and is willing to sign a written informed consent document according to institutional guidelines. Age- and developmentally appropriate assent should be obtained as required by institutional guidelines.

Additional inclusion and exclusion criteria applies and will be discussed with you by the study team.

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Study Description

This clinical trial is testing a new treatment for children and young adults with aggressive brain tumors, including DIPG and high grade glioma with a specific genetic change (H3 K27M mutation). The treatment combines standard radiation therapy with a new medicine called selinexor, which may help stop cancer cells from growing and shrink tumors. Patients receive radiation for 5-7 weeks and take selinexor pills weekly during and after radiation for up to two years. The study will first find the safest dose of selinexor and then test how well it works. MRIs and follow-up visits help monitor progress. Researchers hope this treatment will improve outcomes for these difficult-to-treat brain tumors.

NOTE: Enrollment for DIPG and DMG has been discontinued. This study is only opened for patients with HGG without a H3 K27M mutation. 

Inclusion Criteria

Pre-Enrollment

1. Age: Patients must be 25 years old or younger.
2. Diagnosis: Must have a newly diagnosed high-grade glioma (HGG) that hasn’t spread.
3. Consent: A parent or guardian, or the patient, must sign a consent form.
4. Samples (non-DIPG tumours): Tumour samples from surgery or biopsy need to be submitted soon after the procedure (ideally within 5 days).

Main Enrollment

1. Age: Patients must be between 1 and 21 years old.
2. Diagnosis:
   • DIPG: Must meet specific imaging or biopsy criteria. CLOSED
   • HGG: Must be newly diagnosed, without certain genetic mutations. OPEN
3. Patients need to be in good overall health with normal lab results and no severe symptoms.
4. Enrollment must happen within 31 days of diagnosis or surgery.
5. A signed consent form is required.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

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Study Description

This study is to assess the effectiveness of a drug called Difluoromethylornithine (DFMO) in combination with etoposide for patients with neuroblastoma that has come back, or is not responidng to current treatment. DFMO is a medication taken by mouth. It is an blocker of ornithine decarboxylase, an enzyme involved with polyamine biosynthesis in the cancer cells, including neuroblastoma cells. 

Inclusion Criteria

• Patients less than 31 years of age 
• Diagnosis of neuroblastoma that has come back or is not responding to treatment 
• Patients can have active or no active disease at the time of study start
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study is testing a new treatment for children with DIPG or DMG brain tumors who have recently finished radiation. The treatment combines a vaccine (rHSC-DIPGVax) with two medicines, BALSTILIMAB and ZALIFRELIMAB. The main goal is to see if this combination is safe and can be tolerated. Patients may join if they were diagnosed with DIPG or DMG and completed radiation about 6–10 weeks before entering the study.

Inclusion Criteria

• Participants must be 12 months - 18 years old with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG) 
• Must have measurable tumor on scans
• Body size (BSA) must be at least 0.35 m²
• Must be up and about at least 50% of waking hours 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.